Portico™ NG (Navitor) Valve and FlexNav™ Delivery SystemNavitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
Study summary
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to support CE (Conformité Européenne) Mark and FDA approval.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Key Inclusion Criteria:
1. Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.
2. Subject has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV.
3. Subject has senile degenerative aortic valve stenosis with echo-derived criteria, defined as: aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed EOA (effective orifice area) ≤ 0.6 cm2/m2) AND mean gradient ≥40 mmHg or peak jet velocity ≥ 4.0 m/s or doppler velocity index (DVI) ≤0.25. (Qualifying AVA baseline measurement must be within 90 days prior to informed consent).
4. Aortic annulus diameter of 19-30mm and ascending aorta diameter for the specified valve size listed in the IFU (Instructions For Use), as measured by CT (Computed Tomography)
Key Exclusion Criteria:
1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.
2. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.
3. Blood dyscrasias as defined: leukopenia (WBC\<3000 mm3), acute anemia (Hb \< 9 g/dL), thrombocytopenia (platelet count \<50,000 cells/mm³). History of bleeding diathesis or coagulopathy
4. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
5. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
6. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).
7. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT), severe (greater than or equal to 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise.
8. Minimum access vessel diameter of \<5.0mm for small FlexNav™ Delivery System and \<5.5 mm for large FlexNav™ Delivery System
Primary outcome measure(s)
Primary Safety Endpoint is All-cause Mortality — at 30 days All-cause mortality is defined as the total number of deaths in each cohort at 30 days.
Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak — at 30 days Number of participants with moderate or greater paravalvular leak at 30 days.
Trial sites (28)
Facility
City
Region
Status
Cedars-Sinai Medical Center
Los Angeles
California
Los Robles Regional Medical Center
Thousand Oaks
California
Washington Hospital Center
Washington D.C.
District of Columbia
Advocate Christ Medical Center
Oak Lawn
Illinois
St. Vincent Hospital
Indianapolis
Indiana
Via Christi Regional Medical Center
Wichita
Kansas
Sparrow Clinical Research Institute
Lansing
Michigan
Minneapolis Heart Institute
Minneapolis
Minnesota
Atlantic Health System - Morristown Memorial Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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